EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.
Issue link: https://digital.eyeworld.org/i/153099
August 2013 EW NEWS & OPINION 9 A fresh look at orthokeratology by Ellen Stodola EyeWorld Staff Writer Orthokeratology lenses have developed to address complications and become an effective way to treat myopia O rthokeratology is a term that has been around for several decades, but the technology of today may be different than what you would expect. The contact lenses associated with orthokeratology have changed over the years. Over time, this treatment has been shown to be an effective way to treat myopia with moderate levels of astigmatism and has been gaining legitimacy and attention through published data. Bruce Koffler, MD, Koffler Vision Group, Lexington, Ky.; and Cary Herzberg, OD, president of the International Academy of Orthokeratology and the Orthokeratology Academy of America, Herzberg Optical, Aurora, Ill., spoke on the topic, their work, and views of orthokeratology today. The technology and change over time This technology was basically invented by accident in the 1960s, Dr. Herzberg said. It was discovered that hard contact lenses made out of polymethylmethacrylate (PMMA) tended to flatten the cornea over time as patients wore them. This led to intentional flattening to treat the cornea and improve myopia; however, there were limitations of technology and design to produce lenses that would always center no matter how flat the base curve was fit. Dr. Koffler said these hard contact lenses used during the day would attempt to flatten the central cornea, but often took weeks to months, with not very good results. In the 1990s, newer technology helped evolve these orthokeratology lenses. Advancements were made with new materials that allowed for higher oxygen permeability. "We went to gas permeable materials, rather than just hard materials," he said. As a result, it was possible to wear the lenses safely overnight. Other new technology in the 1990s allowed for computerized cut- ting of the contact lenses, which allowed for reverse geometry lenses where "instead of the lens being steep centrally and gently flattening in the periphery, now we could create a lens that was flat centrally and a little steeper in the periphery." This advancement led to a more specialized design of the lenses. Dr. Koffler said this culminated in an FDA study by Paragon Vision Sciences (Mesa, Ariz.), which resulted in the approval of their lens design and overnight wear for all ages in 2002. It was at this time that the term "corneal refractive therapy" was coined for the technique. Dr. Herzberg said that advances in the field helped to propel the technique forward, especially advances in topography, which "allowed you to measure the elevation of the cornea more accurately." He also mentioned that new computerized lathing systems became available in the 1990s, meaning that "lenses could be manufactured without human involvement." Appeal of the lenses These lenses were appealing for a number of reasons. They offered a non-surgical approach to help myopia. They were also approved as a possible treatment for children. Dr. Koffler said the effect of the lenses is evident overnight and that most people get full correction within a week. "The overnight wear does a couple of things," Dr. Koffler said. "Number one, these lenses don't move much, so the patients are comfortable when they're sleeping." Though they require six to eight hours of sleep, they could still work if someone wore them for the first couple of waking hours. Candidates for the lenses Dr. Koffler said orthokeratology lenses are particularly effective in myopes from about –1.0 D to –5.0 D, and with astigmatism up to about 1.5 D. He said he likes to offer this option to anyone who is a candidate and is looking at treatments beyond glasses. "We custom fit every individual and we can custom fit the central curve, we can custom fit in the mid-periphery of the cornea, and we can custom fit where the lens lands on the limbal or scleral area of the cornea," he said. He said this type of overnight treatment could be particularly helpful in patients with certain lifestyles. For example, swimmers who can't wear contacts when swimming may benefit from this, or it could help those with allergies to be contact lens free during the day. "We fit everybody, but the highest peaks are in the teenage populacontinued on page 12 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use PROLENSA™ (bromfenac ophthalmic solution) 0.07% safely and effectively. See full prescribing information for PROLENSA™ ophthalmic solution. PROLENSA™ (bromfenac ophthalmic solution) 0.07% Initial U.S. Approval: 1997 -----------------INDICATIONS AND USAGE ---------------PROLENSA is a nonsteroidal anti-infammatory drug (NSAID) indicated for the treatment of postoperative infammation and reduction of ocular pain in patients who have undergone cataract surgery. (1) -------------------CONTRAINDICATIONS -----------------None (4) ------------- WARNINGS AND PRECAUTIONS -----------• Sulfte Allergic Reactions (5.1) • Slow or Delayed Healing (5.2) • Potential for cross-sensitivity (5.3) • Increase bleeding of ocular tissues (5.4) • Corneal effects including keratitis (5.5) • Contact Lens Wear (5.6) ------------------- ADVERSE REACTIONS -----------------The most commonly reported adverse reactions in 3 to 8% of patients were anterior chamber infammation, foreign body sensation, eye pain, photophobia, and vision blurred. (6.1). ------------ DOSAGE AND ADMINISTRATION -----------Instill one drop into the affected eye once daily beginning 1 day prior to surgery, continued on the day of surgery, and To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-323-0000, or FDA through the frst 14 days post-surgery. (2.1) at 1-800-FDA-1088 or www.fda.gov/medwatch. -----------DOSAGE FORMS AND STRENGTHS ---------See 17 for PATIENT COUNSELING INFORMATION Topical ophthalmic solution: bromfenac 0.07% (3) Revised: 4/2013 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosing 2.2 Use with Other Topical Ophthalmic Medications 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Sulfte Allergic Reactions 5.2 Slow or Delayed Healing 5.3 Potential for Cross-Sensitivity 5.4 Increased Bleeding Time 5.5 Keratitis and Corneal Reactions 5.6 Contact Lens Wear 6 ADVERSE REACTIONS 6.1 Clinical Trial Experience 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE PROLENSA™ (bromfenac ophthalmic solution) 0.07% is indicated for the treatment of postoperative infammation and reduction of ocular pain in patients who have undergone cataract surgery. 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosing One drop of PROLENSA ophthalmic solution should be applied to the affected eye once daily beginning 1 day prior to cataract surgery, continued on the day of surgery, and through the frst 14 days of the postoperative period. 2.2 Use with Other Topical Ophthalmic Medications PROLENSA ophthalmic solution may be administered in conjunction with other topical ophthalmic medications such as alpha-agonists, beta-blockers, carbonic anhydrase inhibitors, cycloplegics, and mydriatics. Drops should be administered at least 5 minutes apart. 3 DOSAGE FORMS AND STRENGTHS Topical ophthalmic solution: bromfenac 0.07% 4 CONTRAINDICATIONS None 5 WARNINGS AND PRECAUTIONS 5.1 Sulfte Allergic Reactions Contains sodium sulfte, a sulfte that may cause allergic type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfte sensitivity in the general population is unknown and probably low. Sulfte sensitivity is seen more frequently in asthmatic than in non-asthmatic people. 5.2 Slow or Delayed Healing All topical nonsteroidal anti-infammatory drugs (NSAIDs), including bromfenac, may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems. 5.3 Potential for Cross-Sensitivity There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs, including bromfenac. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs. 5.4 Increased Bleeding Time With some NSAIDs, including bromfenac, there exists the potential for increased bleeding time due to interference with platelet aggregation. There have been reports that 8.4 Pediatric Use 8.5 Geriatric Use 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES 14.1 Ocular Infammation and Pain 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION 17.1 Slowed or Delayed Healing 17.2 Sterility of Dropper Tip 17.3 Concomitant Use of Contact Lenses 17.4 Concomitant Topical Ocular Therapy *Sections or subsections omitted from the full prescribing information are not listed. ocularly applied NSAIDs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery. It is recommended that PROLENSA ophthalmic solution be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time. 5.5 Keratitis and Corneal Reactions Use of topical NSAIDs may result in keratitis. In some susceptible patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or corneal perforation. These events may be sight threatening. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs, including bromfenac, and should be closely monitored for corneal health. Post-marketing experience with topical NSAIDs suggests that patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse events which may become sight threatening. Topical NSAIDs should be used with caution in these patients. Post-marketing experience with topical NSAIDs also suggests that use more than 24 hours prior to surgery or use beyond 14 days post-surgery may increase patient risk for the occurrence and severity of corneal adverse events. 5.6 Contact Lens Wear PROLENSA should not be instilled while wearing contact lenses. Remove contact lenses prior to instillation of PROLENSA. The preservative in PROLENSA, benzalkonium chloride may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of PROLENSA. 6 ADVERSE REACTIONS 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not refect the rates observed in clinical practice. The most commonly reported adverse reactions following use of PROLENSA following cataract surgery include: anterior chamber infammation, foreign body sensation, eye pain, photophobia, and vision blurred. These reactions were reported in 3 to 8% of patients.